Zimmer Biomet Recalls Orthopedic Screw Taps Due to Material Anomaly
Zimmer Biomet is recalling 198 nonsterile orthopedic screw taps because raw material anomalies may increase the risk of instrument fracture during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall, and the source text explicitly states the anomaly can increase the risk of instrument fracture, which falls under the rubric criterion for 'structural vehicle defect' or 'significant injury/property-damage reports' by analogy to structural integrity failures in medical devices.
Plain-English summary
Zimmer Biomet, Inc. is recalling 198 units of the Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter (Item Number/EDI 00236015335). These nonsterile orthopedic surgical instruments were distributed nationwide in the United States and internationally to Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan, and Trinidad. The affected lot numbers are 63578494, 63641443, and 63524035.
The recall was initiated because various trauma and extremity instruments, including drill bits and screw taps, were manufactured from raw material with an anomaly. This anomaly may be on or below the surface and can increase the risk of instrument fracture. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for instructions on return or replacement. Consumers are not directly affected as these are professional surgical instruments, but patients who have had these instruments used in their surgery should consult their healthcare provider if they have concerns about instrument integrity.
The recalled product
- Product
- Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 198
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: 63578494
- 63641443 & 63524035.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 60 products in this recall →Related recalls
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Same hazard · instrument fracture
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Similar recalls
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